Cardiohelp-i Transport Guard with Transport Guard — Class II medical device recall Z-0897-2022
Ongoing recall by Maquet Medical Systems USA, reported 2022-04-13, distributed nationwide. Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mec
| Recall number | Z-0897-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Medical Systems USA, Wayne, NJ, United States |
| Recall initiated | 2022-02-18 |
| Classified | 2022-04-08 |
| Reported by FDA | 2022-04-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, DE, HU, KR, MX, MY, PL, SK, TW, ZA |
| UPC / GTIN / UDI-DI | 04058863074863 |
| Serial numbers | 90413945, 90414225, 90414226, 90414227, 90414228, 90414229, 90414232, 90414233, 90414234, 90414235, 90414236, 90414237, 90414283, 90414284, 90414285, 90414286, 90414287, 90414288, 90414289, 90414292, 90414293, 90414294, 90414295, 90414296, 90414297 and 7 more |
| Model numbers | 701072780 |
Product
Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product Code/REF Number: 701072780 (Cardiohelp-i)
Reason for recall
Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly, a full disassembly of the Transport Guard may occur, resulting in a delay of support if a product exchange is necessary.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0897-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.